sterilization of talc

[SHIRLEEN VANOCKER]

I have been asked to sterilize talc that will be used for pleurodesis. I didn't know talc could be sterilized by conventional methods. I am going to contact the mfg. Does anyone out there sterilize talc? would you mind sharing info and a policy ?? Thanks!

[Harvey Johnson]

Back in the "olden days", I heard of talc being sterilized by eto or dry heat methods.
I would ask whoever requested this bring you the talc manufacturer's written instructions for sterilization.....after you get the blank look, direct them toward purchasing and have it delivered sterile.

If they insist, here is a link to an "olden days" article about dry heat sterilization of powders.

http://www.ajronline.org/cgi/content/full/179/1/198

Good Luck!

[klammon]

We no longer will sterilize talc in our facility. We purchase sterile talc in two forms; loose in a bottle, and in tubes for aerosolizing. We purchase it from Bryan Corporation. This is the simplest fix, and is also what's best for our patients.

[chipmoore]

When you purchase a medical device or drug, the instructions for use form the basis for safe and effective outcomes. Producing a drug or reprocessing a Single Use item puts the hospital in a medical device Mfg status. Yes, it's possible to use Dry Heat sterilizers (or sitting in a steam sterilizers for hours with the jacket hot)for powers, but who would end up on the hot seat if the patient has an unhappy outcome, the CS Mgr, that's who. That's because processing powers like Talc is actually a drug and local production at a hospitals makes the hospital a medical device/drug manufacturer with all the regulatory baggage attached. Contact Bryan and purchase prepackaged stuff and even though it might be expenses, it'll be cheap in the long run.
Chip Moore
Getinge
Rochester, NY

[Harvey Johnson]

Hi Chip,
I appreciate your input, it's true in house sterilizing of talc is not the best policy.
However, I must take you to task on your opinion about the process.
I think you are confusing initial single use sterilization with resterilization of single use items.
Quoting the AAMI ST 79 standards book, (8.5.8, A.6 and 6.2) "if manufacturers instructions are obtained, dry heat is the recommended method to sterilize powders such as talc" and it goes on to describe the process.
ST 79 mentions nothing about a drug classification for talc or that it places the facility in a single use reprocessor catagory. Are you able to site a source to substantiate your claim?
As bad as the practice is, you shouldn't be placing fear of regulatory violations where there appears to be none.
(Again, just my opinion, your mileage may vary.....)

Harvey Johnson
Tuality Healthcare
Hillsboro, Oregon

[chipmoore]

Hi Harvey,
My hat off to you for having the brand new ST79 in your posession. Congratulations.
I also found 8.5.8 in ST79 but could not find the other two. 8.5.8 simply states Powers (such as talc) cannot be steam sterilized, use dry heat and follow ST40-1992. So I can not find your quoted reference, tell me again.
ST79 won't mention drug classification or regulatory inplications, but I do know our medical device laws. My reference to reprocessing single use items was to illustrate the FDA's view of a hospital reprocessing a single use item, which would put the facility in a device Mfg status. Same for Talc. If the hospital produces a drug (sterile Talc) for patient use, they would fall under the federal laws for medical device/drug. The same would apply if a hospital "sold" a sterilization service to a local hospital or surgery center not under the corporate umbrella. The FDA exempts hospital from all the regulatory stuff because of safe and effective Mediacl device Intended Use labeling, and also because of AAMI, IAHCSMM, ASHCSP and JCAHO.
My point is this, something bad happens with the sterile talc produced by the hospital. The injured party's lawyer will ask the CS Mgr, the resident sterilization expert, for copies of the Talc Mfg sterilization instructions and there won't be any because the don't exist. Case closed and the CS Mgr can only hope the jury is in a good mood that day.
Am I trying to place fear? You bet. Maybe this communication method isn't the best and maybe the words written in this email thread lack clearity, but I can assure you, processing Talc in your CS department places the hospital in the medical device Mfg status just as it would if they process single use items. Check it out with your Risk Mgr or hospital lawyer.
Thanks for the reply and send another one if there are still confusion
Chip Moore
Getinge
Rochester, NY

[Harvey Johnson]

Chip,
Considering that snide opening remark, mabe we should take this to the PM area, I think we are no longer at the discussion stage.
Let me make this clear....there "are" no confusion at this end.
I am not defending nor does our hospital approve in house sterilization of talc, I am just questioning your method of proving a point!
I cited my references from AAMI, check the ST79 index if you need more guidance.
But if you insist on help, ST 79, page 413, section 6.2, last paragraph, last sentence reads "Talc in volume is also a barrier to EO penetration and is generally sterilized by dry heat (see also OR Manager 1992)."
No condemnation, no reference to a drug, no refernce to reprocessing violations.
Wouldn't the fact it is included in ST 79 without a note of condemnation mean anything?
I have yet to see you cite references for your claims....
Talk is a drug?
Sterilizing it is producing a drug?
Sterilizing it for the first time is reprocessing it?
Talc is not "resterilized" when processed sterile for the first time.
As for your claim that no instructions exist for sterilizing talc, then how do the folks you recommended at Bryan achieve the sterile product to sell?
I see you are also a legal expert and also able to predict jury trial outcomes, is that why you still insist on the fear factor to prove your points?
A little education relieves a lot of fear and with all the expertise Getinge has apparently bestowed upon you, try educating us!
Come on Chip, let's have a discussion with some substance, not hyperbole!

[chipmoore]

Hello again,
My first line was a compliment, sorry you took it wrong. As a long term AAMI, IAHCSMM and ASHCSP member, it would please me if every CS and OR Mgr had AAMI reference documents and better, used them.
My ST79 only has 189 printed pages, the actual ST79 ends on page 114, the rest is informative, so help me again with your referenced pages. Section 6.2 (page 38) is titled Separation of waste.
Paragraph 8.5.8 is on page 68 and doesn't match what you noted.
So, I could still use some help finding the references.

Here's a link about FDA clearance to Bryan producing sterile talc. I searched using "Sterile talc" and got lot's of hits but thought the one below supported that producing sterile talc was, indeed, a drug.
http://www.ashp.org/news/ShowArticle.cfm?id=3685
I called Bryan (781 935 0004) to ask them about requirements in producing sterile talc. They referred me to http://www.usp797.org/ to document that sterile talc is, indeed, a drug subject to all regulatory/labeling requirement for use.
I understand USP797 function is to discourage the production of drugs for patient use within hospital walls. The people at Bryan told me the got FDA approval for their talc through the New Drug Application process and the following site might offer additional regulatory information
http://www.fda.gov/cder/
I really don't think the email exchanges on this topic is all bad. I can understand your need to "see" documentation of the legal aspects of what I've indicated and I hope everyone understands my point. That is the production of a drug for patient use is regulated. Hospital processing of single use devices is also regulated. Here's a site to verify:
http://www.fda.gov/cdrh/reuse/testimony-092606.html

This will be my last input on the subject because it's about run it's course. I sincerely hope the dialog has been productive for all. If fear tactics causes reactions leading to understanding, great.
Chip Moore
Getinge
Rochester. NY

[Harvey Johnson]

Hi Chip,
I agree, I'm exausted, let's have a drink and call it a day.....
I appreciate the references, they are helping me understand.
The AAMI book we purchased, the standards collection, Sterilization, Part 1, "Sterilization in Health Care Facilities", which contains ST 79 and other AAMI sections totaling over 1000 pages and is very informative. It's about $250.00 / $350.00 for non members.
Thanks again for the discussion, after all that's why the board is here.

[SHIRLEEN VANOCKER]

to Chip and Harvey; Well, I sure got the info I needed to make an informed decision about sterilization of talc! We won't be doing this, we will be purchasing sterile talc from Bryan. I thank you both for the input and for information as to where to purchase. Thank you both!